Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey

Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey: A Prospective Multicenter Study Including 69 NICUs

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02814929

Acronym

TR-ROP

Enrollment

6115

Registered

2016-06-28

Start date

2016-04-01

Completion date

2017-10-17

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Keywords

ROP, Risk factors, Incidence, Turkey

Brief summary

The study includes preterm infants who are being screened for ROP between April 1,2016 and April 30, 2017 in 69 neonatal intensive care units (NICUs) in Turkey. Infants with birth weight (BW) of ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or gestational age (GA) \>32 weeks with an unstable clinical course are included. The incidence of any ROP, severe ROP and treatment modalities will be determined. The risk factors for ROP development will also be evaluated.

Detailed description

This study, promoted by the Turkish Neonatology Society, involved preterm infants who are being screened for ROP between April 1, 2016 and April 30, 2017 in level III Turkish NICUs. An electronic questionnaire is being filled by certified neonatologists in Turkey via a special network. Neonatologists working in 69 centers who agreed to participate in this study provide their data regarding the ROP in their NICU. The medical records of retinal examinations of preterm infants who met the screening criteria will be evaluated. A case report form for each patient will be filled including risk factors for the development of ROP such as gestational age, birth weight, small for gestational age (SGA), gender, multiple gestation, antenatal steroid therapy, invitro fertilisation, preeclampsia/eclampsia, infants of diabetic mother, chorioamnionitis, resuscitation in delivery room, respiratory distress syndrome (RDS), duration of mechanical ventilation and oxygen therapy, intracranial hemorrhage, hemodynamically significant patent ductus arteriosus (PDA), early/late sepsis, necrotising enterocolitis (NEC), number of blood transfusions, bronchopulmonary dysplasia (BPD), weight gain at postnatal 28th days and breastfeeding. Risk factors for developing ROP will be evaluated. Multivariate analysis will be performed among significant variables. In addition, the incidence of any ROP, severe ROP in relation to GA and BW and treatment modalities will be determined. Severe ROP is defined as ROP requiring treatment. Since Turkey is receiving many refugees in recent years, the investigators also planned to evaluate the incidence and risk factors for developing ROP in preterm babies of refugees. Ophthalmologic examination is continued until full vascularisation. So, the maximum stage of ROP detected for every infant will be reported. Data from 69 NICUs will be pooled together and analyzed. The International Classification of ROP guidelines are used to record stage of disease, location by zone, signs of plus disease and signs of regression. Criteria for treatment of ROP are based on the Early Treatment for Retinopathy of Prematurity (ETROP) recommendation. Confirmed forms are also assigned by the parents before the initial screening and treatment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

28 Days to No maximum

Healthy volunteers

Inclusion criteria

* Infants with BW ≤1500 g or ≤32 weeks' gestation and those with a BW of greater than 1500 g or GA \>32 weeks requiring cardiorespiratory support and who were determined by the attending clinician to be at risk for ROP, are included.

Exclusion criteria

* Neonates who died before the first ROP examination are excluded from the study.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of ROP in Turkey	12 months	Incidence of ROP and severe ROP in relation to GA and BW in Turkey

Secondary

Measure	Time frame	Description
The association of antenatal corticosteroid administration with ROP	12 months	—
The role of sepsis in infants in the development of ROP	12 months	Culture proven and clinical early and late sepsis will be evaluated
The relationship between rate of postnatal weight gain and severity of ROP	12 months	—
The relationship between breastfeeding and ROP development	12 months	—
ROP in SGA premature infants	12 months	Comparison of ROP in SGA infants with those of appropriate size for GA
The role of transfusions in ROP development	12 months	—
Duration of oxygen therapy among infants with and without ROP	12 months	—
Number of patients requiring laser photocoagulation treatment	12 months	—
Number of patients requiring vitreoretinal surgery	12 months	—
Number of patients requiring anti-vascular endothelial growth factor treatment	12 months	—
ROP in multiple births	12 months	Comparison of the frequency and severity of ROP among singleton and multiple-birth neonates

Other

Measure	Time frame	Description
Incidence of ROP in preterm babies of refugees in Turkey	12 months	Incidence of any ROP and severe ROP in relation to GA and BW in preterm babies of refugees

Countries

Turkey (Türkiye)

Outcome results